Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis (NCT06391164) | Clinical Trial Compass
UnknownPhase 2
Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis
Russia280 participantsStarted 2024-04
Plain-language summary
Multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of XC243 in patients with exacerbation of chronic cystitis. It is planned to include patients with chronic cystitis in 4 parallel groups, who will receive XC243 at a dose of 25 mg per day, 50 mg per day, 75 mg per day or placebo for 7-10 days. Efficacy will be assessed by time from first study treatment to resolution of the symptom "Pain, discomfort or burning when urination " assessed on a visual-analog scale (VAS).
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Availability of the Form signed and dated by the patient the Patient Information Leaflet informed consent (IMP).
✓. Women aged 18 to 65 years inclusive at the time of signing the Informed IMP consent.
✓. Established diagnosis of chronic bacterial cystitis (at least three relapses chronic cystitis within 12 months prior to screening or two cases within 6 months prior to screening, including relapse at study entry).
✓. The presence of symptoms characteristic of exacerbation of chronic cystitis: pain syndrome (pain in lower abdomen, when urinating), dysuric symptoms (increased urination, pain or burning when urinating, urgency to urinate, feeling of incomplete emptying bladder).
✓. The appearance of symptoms of exacerbation of chronic cystitis is not \> 48 hours prior to screening visit.
✓. Severity of the symptom "Pain, discomfort or burning with urination "from 4 to 8 VAS points.
✓. No therapy for current cystitis exacerbation (including phosphomycin and/or furasidin for the treatment of current exacerbation).
✓. The patient's consent to refrain from drinking alcoholic beverages during the period of participation in study.
Exclusion criteria
✕. Hypersensitivity to the active and/or any of excipients of the test drug.
✕. Hypersensitivity to furasidine and/or any of the excipients concomitant medication.
What they're measuring
1
Time from the first dose of IP treatment until the symptom "Pain, discomfort or burning when urination " disappears (decreases).